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One may be performed to aid the planning of a clinical trial, specifically setting the sample size or to support decisions about whether or not to perform a study. Immuno\u2010oncology is a rapidly evolving area in the development of anticancer drugs. A common phenomenon that arises in trials of such drugs is one of delayed treatment effects, that is, there is a delay in the separation of the survival curves. To calculate assurance for a trial in which a delayed treatment effect is likely to be present, uncertainty about key parameters needs to be considered. If uncertainty is not considered, the number of patients recruited may not be enough to ensure we have adequate statistical power to detect a clinically relevant treatment effect and the risk of an unsuccessful trial is increased. We present a new elicitation technique for when a delayed treatment effect is likely and show how to compute assurance using these elicited prior distributions. We provide an example to illustrate how this can be used in practice and develop open\u2010source software to implement our methods. Our methodology has the potential to improve the success rate and efficiency of Phase III trials in immuno\u2010oncology and for other treatments where a delayed treatment effect is expected to occur.<\/jats:p>","DOI":"10.1002\/sim.10136","type":"journal-article","created":{"date-parts":[[2024,6,17]],"date-time":"2024-06-17T06:15:11Z","timestamp":1718604911000},"page":"3595-3612","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Assurance methods for designing a clinical trial with a delayed treatment effect"],"prefix":"10.1002","volume":"43","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2584-3640","authenticated-orcid":false,"given":"James A.","family":"Salsbury","sequence":"first","affiliation":[{"name":"The School of Mathematics and Statistics The University of Sheffield  Sheffield UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeremy E.","family":"Oakley","sequence":"additional","affiliation":[{"name":"The School of Mathematics and Statistics The University of Sheffield  Sheffield UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9917-7636","authenticated-orcid":false,"given":"Steven A.","family":"Julious","sequence":"additional","affiliation":[{"name":"The School of Health and Related Research The University of Sheffield  Sheffield UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lisa V.","family":"Hampson","sequence":"additional","affiliation":[{"name":"Advanced Methodology and Data Science Novartis Pharma AG  Basel Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,6,16]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.4780050103"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/pst.175"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1201\/9781003218531"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.2488"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/pst.2179"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1002\/pst.1717"},{"key":"e_1_2_9_8_1","volume-title":"22 Case Studies where Phase 2 and Phase 3 Trials Had Divergent Results","author":"US Food and Drug Administration","year":"2017"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1002\/pst.1854"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/pst.1856"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1056\/nejmoa1504627"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaoncol.2022.2666"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaoncol.2020.0237"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1056\/nejmoa1917346"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaoncol.2020.3370"},{"key":"e_1_2_9_16_1","unstructured":"International Council for Harmonisation.Addendum on estimands and sensitivity analysis in clinical trials to the guideline om statistical principles for clinical trials E9(R).2019. 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